A Single-arm, Prospective Phase Ⅱ Clinical Study of Utidelone Combined with Capecitabine in the Treatment of Active Brain Metastasis of TNBC

Excluded: HER2 (ERBB2) overexpression

the definition of negative human epidermal growth factor receptor 2(HER2): the immunohistochemistry (IHC) is 0 or 1+; If IHC was 2+, it was confirmed negative by fluorescence in situ hybridization (FISH)

Excluded: ESR1 expression

Negative estrogen ... IHC examination shows ER < 10%

Excluded: PR (PGR) expression

Negative ... progesterone receptors means that IHC examination shows ... PR < 10%

Must have received: taxane — neoadjuvant, adjuvant, or metastatic

previously received at least one taxane ... (as a treatment history of neoadjuvant therapy, adjuvant therapy or metastatic therapy or both)

Must have received: anthracycline — neoadjuvant, adjuvant, or metastatic

previously received at least one ... anthracycline antibiotic (as a treatment history of neoadjuvant therapy, adjuvant therapy or metastatic therapy or both)

Cannot have received: chemotherapy

Received chemotherapy ... within 2 weeks before joining the group

Cannot have received: targeted therapy

Received ... targeted therapy ... within 2 weeks before joining the group (the interval between targeted therapy and immunotherapy is at least 2 weeks or at least 5 half-lives, whichever is shorter)

Cannot have received: immunotherapy

Received ... immunotherapy within 2 weeks before joining the group (the interval between targeted therapy and immunotherapy is at least 2 weeks or at least 5 half-lives, whichever is shorter)

Cannot have received: endocrine therapy

Received endocrine therapy within 1 week before joining the group

Cannot have received: alkylating agent (nitrosourea, mitomycin)

He had received nitrosourea or mitomycin chemotherapy within 6 weeks before joining the group

Cannot have received: investigational agent

Receive unlisted clinical trial drugs within 4 weeks before entering the group